BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    GUIDE WIRE

    K Number: K813026 · Decision Nov 17, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    91
    Registration Numbers
    91
    Same Product Code
    42
    Applicant Total
    32
    Review Days
    20

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    GUIDE WIRE
    K Number
    K813026
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Inmed Corp.
    Date Received
    October 28, 1981
    Decision Date
    November 17, 1981
    Product Code
    OCY
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OCY Endoscopic Guidewire, Gastroenterology-Urology

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (OCY), ordered by most recent decision date.

    EasyPass Guidewire

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Radifocus Glidewire Endoscopic Wire

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic Guidewire straight stiff, Orchestra Hydrophilic Guidewire angled stiff,Orchestra Hydrophilic Guidewire standard straight, Orchestra Hydrophilic Guidewire straight stiff

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    NovaGold High Performance Guidewire

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Acrobat Calibrated Tip Wire Guide

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    JAGWIRE HIGH PERFORMANCE GUIDWIRE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by Inmed Corp.

    K Number Device Name
    K862672 ESOPHAGEAL STETHOSCOPE WITH THERMISTOR
    K853162 STERILE NASOPHARYNGEAL AIRWAY
    K850152 PRECONNECTED URETHRAL CATHETER TRAY
    K850335 URETEROSCOPY CATHETER
    K850248 DISPOSABLE GUEDEL AIRWAY
    K844801 ULTRA EXTERNAL CATHETER
    K842301 DISPOSABLE LATEX BANDAGE
    K842866 URETHRAL CATHETERIZATION TRAY
    K841040 FOX POST NASAL BALLOON CATHETER
    K842865 ESOPHAGEAL STETHOSCOPE
    Search all 32 clearances from Inmed Corp. →